Trial · NCT01746784
Safety and Pharmacokinetic Study of N6022 in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation
NCT01746784, Phase 1, Completed, Nivalis Therapeutics, Inc.; results first posted 2014-11-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Pharmacokinetic Study of N6022 in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation. Trials, record NCT01746784. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01746784
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Pharmacokinetic Study of N6022 in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation
- NCT number
- NCT01746784
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 66 participants, actual
- Lead sponsor
- Nivalis Therapeutics, Inc.
- Conditions
- Cystic Fibrosis
- Interventions
- N6022, Normal saline
- First posted
- 2012-12-11
- Last updated
- 2014-11-24
- Results first posted
- 2014-11-24
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and Tolerability | Over 7 treatment days and 7 days of follow-up | Assessments are based on numbers of subjects with abnormal clinical evaluations, abnormal laboratory assessments, and adverse events. |
| Secondary | Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) | Change from baseline at Day 7 | FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson standards were used to calculate percent predicted FEV1 (for age, sex, and height). |
| Secondary | Change in Biomarkers of CFTR Function | Change from baseline at Day 7 | Sweat chloride millequivalents/Liter (mEq/L) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety and Tolerability | Over 7 treatment days and 7 days of follow-up | Treatment emergent adverse events by Grade 1 (mild) to 5 (fatal) | participants | NUMBER |
| SECONDARY | Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) | Change from baseline at Day 7 | Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to Study Day 7 | percentage | MEAN |
| SECONDARY | Change in Biomarkers of CFTR Function | Change from baseline at Day 7 | Change from baseline sweat chloride (mEq/L) to Study Day 14 | mEq/L | MEAN |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety and Tolerability | Normal Saline | Grade 1 (mild) | 11 | participants | |
| Safety and Tolerability | 5mg/N6022 | Grade 1 (mild) | 4 | participants | |
| Safety and Tolerability | 10mg/N6022 | Grade 1 (mild) | 6 | participants | |
| Safety and Tolerability | 20mg/N6022 | Grade 1 (mild) | 4 | participants | |
| Safety and Tolerability | 40mg/N6022 | Grade 1 (mild) | 12 | participants | |
| Safety and Tolerability | Normal Saline | Grade 2 (moderate) | 6 | participants | |
| Safety and Tolerability | 5mg/N6022 | Grade 2 (moderate) | 3 | participants | |
| Safety and Tolerability | 10mg/N6022 | Grade 2 (moderate) | 3 | participants | |
| Safety and Tolerability | 20mg/N6022 | Grade 2 (moderate) | 5 | participants | |
| Safety and Tolerability | 40mg/N6022 | Grade 2 (moderate) | 2 | participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo/Saline | 19 | |
| Overall Study | STARTED | 5 mg/N6022 | 10 | |
| Overall Study | STARTED | 10 mg/N6022 | 9 | |
| Overall Study | STARTED | 20mg/N6022 | 9 | |
| Overall Study | STARTED | 40 mg/N6022 | 19 | |
| Overall Study | Enrolled | Placebo/Saline | 19 | |
| Overall Study | Enrolled | 5 mg/N6022 | 10 | |
| Overall Study | Enrolled | 10 mg/N6022 | 9 | |
| Overall Study | Enrolled | 20mg/N6022 | 9 | |
| Overall Study | Enrolled | 40 mg/N6022 | 19 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events125
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Placebo/Saline | 1 | 19 | 1 |
| other | Headache | Nervous system disorders | 5 mg/N6022 | 1 | 10 | 1 |
| other | Headache | Nervous system disorders | 10 mg/N6022 | 1 | 9 | 1 |
| other | Headache | Nervous system disorders | 20mg/N6022 | 2 | 9 | 2 |
| other | Headache | Nervous system disorders | 40 mg/N6022 | 1 | 19 | 1 |
| other | Parosmia | General disorders | Placebo/Saline | 0 | 19 | 0 |
| other | Parosmia | General disorders | 5 mg/N6022 | 0 | 10 | 0 |
| other | Parosmia | General disorders | 10 mg/N6022 | 0 | 9 | 0 |
| other | Parosmia | General disorders | 20mg/N6022 | 2 | 9 | 2 |
| other | Parosmia | General disorders | 40 mg/N6022 | 0 | 19 | 0 |
1 to 10 of 125Source ClinicalTrials.gov
See all 125 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo/Saline | ||
| Total, all-cause mortality | 5 mg/N6022 | ||
| Total, all-cause mortality | 10 mg/N6022 | ||
| Total, all-cause mortality | 20mg/N6022 | ||
| Total, all-cause mortality | 40 mg/N6022 | ||
| Total, other adverse events | Placebo/Saline | 18 | 19 |
| Total, other adverse events | 5 mg/N6022 | 9 | 10 |
| Total, other adverse events | 10 mg/N6022 | 9 | 9 |
| Total, other adverse events | 20mg/N6022 | 9 | 9 |
| Total, other adverse events | 40 mg/N6022 | 15 | 19 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01746784
GET https://conductscience.org/api/trials/v1/NCT01746784/results?page=2